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Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01049750
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability Score)questionnaires.

Condition or disease Intervention/treatment
Type 2 Diabetic Patients Erectile Dysfunction Other: type 2 diabetic patients

Study Design

Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : June 2009
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
type 2 diabetic patients
males; type 2 diabetic patients
Other: type 2 diabetic patients
males; type 2 diabetic patients


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of erectile dysfunction [ Time Frame: Baseline (time 0); 3 months; 6 months ]
  2. Description of erectile disfunction markers [ Time Frame: Baseline (time 0); 3 months; 6 months ]
  3. Evaluation of diabetic neuropathy in patients with erectile dysfunction [ Time Frame: Baseline (time 0); 3 months; 6 months ]

Secondary Outcome Measures :
  1. Metalloproteinases 2 and 9 [ Time Frame: Baseline (time 0); 3 months; 6 months ]
  2. Insulin-sensitivity index (HOMA index) [ Time Frame: Baseline (time 0); 3 months; 6 months ]
  3. Glycemic control [ Time Frame: Baseline (time 0); 3 months; 6 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
males with type 2 diabetes mellitus
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus

Exclusion Criteria:

  • type 1 diabetes mellitus
  • < 18 years old
  • anatomic abnormalities of the penis
  • patients taking erectile dysfunction therapy at the moment of the enrollment
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049750


Locations
Italy
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
University of Pavia
Investigators
Principal Investigator: Giuseppe Derosa, MD, PhD University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia
More Information

Publications:
Responsible Party: Giuseppe Derosa, Professor, University of Pavia
ClinicalTrials.gov Identifier: NCT01049750     History of Changes
Other Study ID Numbers: 20090001127
P-20090002836 ( Registry Identifier: 20090002304 )
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Giuseppe Derosa, University of Pavia:
type 2 diabetes mellitus
male
erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders